Myopia
Conditions
Brief summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
Detailed description
The study will be a prospective, randomized, single blind, bilateral dispensing study
Interventions
DEVICETest Lens 1
Investigational soft contact lens with asperic optical design to control myopia progression.
DEVICETest Lens 2
Investigational soft contact lens with asperic optical design to control myopia progression.
DEVICEControl Lens
Spectacle Lenses.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Myopic subjects between 8 and 12 years of age. 2. The subject best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes) 3. Astigmatism must be less than or equal to 1.00D 4. 1.00D or less difference in spherical equivalent between the two eyes 5. The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes 6. The subject must have at least 8D of accommodation 7. The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT 8. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with lens wear. 3. Clinically significant (grade 3 or 4)corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear. 4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear. 5. Any ocular infection. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV) 8. Diabetes 9. Anisometropia of greater than 1.00D 10. Astigmatism of greater than 1.00D in either eye 11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. 12. Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye. 13. Strabismus in either eye 14. Pupil orr lid abnormality or infection in either eye 15. Central corneal scar in either eye 16. Aphakia in either eye 17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear. 18. History of participation in prior clinical trials aimed to control myopia progression 19. Surgically altered eyes, ocular infection of any type, ocular inflammation 20. Subject has anterior chamber angle grade 2 or narrower
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical Equivalent Refraction | Baseline and every 6 months post-baseline for 2 years | Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia. |
| Axial Length (Axial Elongation) | Baseline and every 6 months post-baseline for 2 years | Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up. |
Countries
China
Participant flow
Pre-assignment details
Of those 150 screened subjects, 3 were not eligible to participate in the study and 10 were not randomized to the study lens groups. 115 subjects completed all study visits without a major protocol deviation.
Participants by arm
| Arm | Count |
|---|---|
| Test Lens 1 Investigational soft contact lens worn daily. | 46 |
| Test Lens 2 Investigational soft contact lens worn daily. | 44 |
| Control Lens Spectacle lenses worn daily. | 47 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Difficulty of handling lens | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 4 | 0 |
Baseline characteristics
| Characteristic | Test Lens 1 | Total | Control Lens | Test Lens 2 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 137 Participants | 47 Participants | 44 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.8 years STANDARD_DEVIATION 1.1 | 9.8 years STANDARD_DEVIATION 1.1 | 9.7 years STANDARD_DEVIATION 1.2 | 9.8 years STANDARD_DEVIATION 1.2 |
| Region of Enrollment China Ch | 46 Participants | 137 Participants | 47 Participants | 44 Participants |
| Sex: Female, Male Female | 30 Participants | 78 Participants | 26 Participants | 22 Participants |
| Sex: Female, Male Male | 16 Participants | 59 Participants | 21 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 44 | 0 / 47 |
| serious Total, serious adverse events | 0 / 46 | 0 / 44 | 0 / 47 |
Outcome results
Primary
Axial Length (Axial Elongation)
Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.
Time frame: Baseline and every 6 months post-baseline for 2 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens 1 | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.214 millimeter (mm) | Standard Deviation 0.102 |
| Test Lens 1 | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.401 millimeter (mm) | Standard Deviation 0.1816 |
| Test Lens 1 | Axial Length (Axial Elongation) | Change from baseline 18 months | 0.564 millimeter (mm) | Standard Deviation 0.2371 |
| Test Lens 1 | Axial Length (Axial Elongation) | Change from baseline 24 months | 0.660 millimeter (mm) | Standard Deviation 0.2355 |
| Test Lens 2 | Axial Length (Axial Elongation) | Change from baseline 24 months | 0.529 millimeter (mm) | Standard Deviation 0.2378 |
| Test Lens 2 | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.198 millimeter (mm) | Standard Deviation 0.1128 |
| Test Lens 2 | Axial Length (Axial Elongation) | Change from baseline 18 months | 0.522 millimeter (mm) | Standard Deviation 0.2643 |
| Test Lens 2 | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.382 millimeter (mm) | Standard Deviation 0.1974 |
| Control Lens | Axial Length (Axial Elongation) | Change from baseline 24 months | 0.749 millimeter (mm) | Standard Deviation 0.3203 |
| Control Lens | Axial Length (Axial Elongation) | Change from baseline 12 months | 0.458 millimeter (mm) | Standard Deviation 0.2323 |
| Control Lens | Axial Length (Axial Elongation) | Change from baseline 18 months | 0.622 millimeter (mm) | Standard Deviation 0.2805 |
| Control Lens | Axial Length (Axial Elongation) | Change from baseline 6 months | 0.263 millimeter (mm) | Standard Deviation 0.1766 |
Primary
Spherical Equivalent Refraction
Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.
Time frame: Baseline and every 6 months post-baseline for 2 years
Population: Analysis was conducted on all randomized subjects who have at least one data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens 1 | Spherical Equivalent Refraction | Change from baseline 6 months | -0.326 diopter (D) | Standard Deviation 0.6678 |
| Test Lens 1 | Spherical Equivalent Refraction | Change from baseline 12 months | -0.898 diopter (D) | Standard Deviation 0.4695 |
| Test Lens 1 | Spherical Equivalent Refraction | Change from baseline 18 months | -1.222 diopter (D) | Standard Deviation 0.8501 |
| Test Lens 1 | Spherical Equivalent Refraction | Change from baseline 24 months | -1.506 diopter (D) | Standard Deviation 0.9346 |
| Test Lens 2 | Spherical Equivalent Refraction | Change from baseline 24 months | -1.376 diopter (D) | Standard Deviation 0.5891 |
| Test Lens 2 | Spherical Equivalent Refraction | Change from baseline 6 months | -0.460 diopter (D) | Standard Deviation 0.3938 |
| Test Lens 2 | Spherical Equivalent Refraction | Change from baseline 18 months | -1.185 diopter (D) | Standard Deviation 0.655 |
| Test Lens 2 | Spherical Equivalent Refraction | Change from baseline 12 months | -0.859 diopter (D) | Standard Deviation 0.4955 |
| Control Lens | Spherical Equivalent Refraction | Change from baseline 24 months | -1.809 diopter (D) | Standard Deviation 0.9485 |
| Control Lens | Spherical Equivalent Refraction | Change from baseline 12 months | -0.905 diopter (D) | Standard Deviation 0.5918 |
| Control Lens | Spherical Equivalent Refraction | Change from baseline 18 months | -1.336 diopter (D) | Standard Deviation 0.7361 |
| Control Lens | Spherical Equivalent Refraction | Change from baseline 6 months | -0.430 diopter (D) | Standard Deviation 0.3942 |